16 results · 37ms · Sources: EU EUDAMED, US FDA

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UROPOWER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MedGyn Pipette

FDA UDI
MEDGYN PRODUCTS, INC.·M803022721·MedGyn Pipette 3.1mm O.D.

MedGyn Pipette

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Medgyn International, Inc·1 device

AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

EQUALIZER BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ALTRX +4 NEUT 44IDX64OD

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 27, 2013

MULTI-LINK 8

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MAF·March 17, 2011

SIX SHOOTER MULTI-BAND LIGATOR (DEVICE 1 OF 2)

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code MND·March 26, 2008

OT SURESTEP METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·March 31, 2011

OT SURESTEP ENHANCED METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·August 23, 2011

OT SS ENHANCED METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·April 11, 2011

OT SS ENHANCED METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·October 14, 2010

BD DISCARDIT¿ II SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 3, 2018

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014